[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nerviano Medical Sciences\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":88},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,63],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100587620","phase-1-study-of-nms-03305293-in-adult-patients-with-relapsed-ovarian-cancer-100587620",false,"NCT06930755","Study of NMS-03305293 in Adult Patients With Relapsed Ovarian Cancer","Study of NMS-03305293, a Non-Trapping PARP1-Specific PARP Inhibitor in Relapsed Ovarian Cancer","Inclusion Criteria -\n\n* Histologically confirmed diagnosis of high-grade serous epithelial ovarian, fallopian tube or peritoneal cancer. Sponsor might opt to restrict enrollment to either platinum refractory, primary or secondary platinum-resistant patients based on data emerging from the trial.\n* Patients must have received no more than 5 prior lines of therapy and failed all evidence based local standards of care as per Investigator judgment. Sponsor might opt to restrict prior lines of therapy to 3 in any moments, based on data emerging from the trial.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n* Patient must have progressed radiographically on or after their most recent line of anticancer therapy and have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (radiologically measured by the Investigator).\n* Resolution of all acute toxic effects (excluding alopecia) of any prior anticancer therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0) Grade ≤ 1 or to the baseline laboratory values as defined in the protocol\n* Patients with childbearing potential must use highly effective contraception or true abstinence.\n\nExclusion Criteria -\n\n* Current enrollment in another interventional clinical trial.\n* Current treatment with other anticancer agents or devices.\n* BReast CAncer gene (BRCA) mutation.\n* Prior therapy with PARP inhibitor, outside of approved indication and schedules. Sponsor might opt to restrict prior use of PARP inhibitor (PARPi) in any moments, based on data emerging from the trial.\n* Prior therapy with topoisomerase inhibitors including payloads of Antibody-Drug Conjugates (ADCs). Sponsor has the option to allow prior ADC, if not last line of treatment, prior to enrollment.\n* Major surgery, other than surgery for recurrent Ovarian Cancer (OC), within 4 weeks prior to treatment start.\n* Patients with low-grade\u002Fborderline ovarian tumor.\n* Prior anti-tumor treatment within 2 weeks prior to treatment start or 5 half-lives, whichever is shorter.\n* Patients with prior wide-field radiotherapy (RT) affecting at least 20 percent of the bone marrow.\n* Use of full-dose anticoagulants unless the INR or activated thromboplastin time (aPTT) is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose of anticoagulants for at least 2 weeks before enrollment.\n* Treatment with concomitant medications known to be sensitive substrates of CYP2D6 and CYP2C19 that cannot be replaced with another treatment.\n* History of interstitial lung disease or relevant lung disease in the opinion of the Investigator.\n* Treatment with systemic immune modulators such as corticosteroids at prednisone equivalent dose of \\> 10 mg\u002Fday, cyclosporine and tacrolimus or radiotherapy within 28 days before Cycle 1 Day 1.\n* Pregnant women. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within the screening period prior to start of study drug.\n* Breast-feeding women or women planning to breast feed during the study or within 3 months after study treatment.\n* Known hypersensitivity to any component of NMS-03305293 or topotecan drug formulations.\n* Known active, life-threatening or clinically significant uncontrolled systemic infection (bacterial, fungal, viral including Human Immunodeficiency Virus (HIV) positivity or Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infections) requiring systemic treatment; HIV or AIDS-related illness are allowed as long as controlled more than 6 months to undetectable on anti-HIV medications.\n* Patients with QTc interval ≥ 450 milliseconds or with risk factors for torsade de pointes (e.g., uncontrolled heart failure, uncontrolled hypokalemia, history of prolonged QTc interval or family history of long QT syndrome). For patients receiving treatment with concomitant medications known to prolong the QTc interval, replacement with another treatment prior to enrollment is mandatory. If concomitant use of anti-emetics is considered essential for the care of the patients, follow instruction in this protocol.\n* Known active gastrointestinal disease (e.g., documented gastrointestinal ulcer, Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes or structural issues or ulcer that would impact on drug absorption.\n* Any of the following in the previous 6 months: myocardial infarction, unstable angina, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, active bleeding disorder and interstitial lung disease.\n* History of long QT disorder or familial sudden death syndromes or related syndromes in the opinion of the Investigator.\n* Currently active second malignancy, except for adequately treated basal or squamous cell skin cancer and\u002For cone biopsied or post curative intention in situ carcinoma of the cervix uteri and\u002For superficial bladder cancer.\n* Symptomatic, or untreated Central Nervous System (CNS) lesions except stable and well-controlled with no neurological symptoms; patients receiving corticosteroids to control neurological symptoms should be on stable doses for at least 14 days before study entry.\n* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study or could compromise protocol objectives in the opinion of the Investigator and\u002For the Sponsor.\n\nNOTE: Other protocol defined inclusion and exclusion criteria may apply.","FEMALE","18 Years",{"count":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a multicenter, open-label Phase Ia\u002Fb study on the safety and efficacy of the combination of NMS-03305293 and topotecan in patients with recurrent ovarian cancer, with dose-limiting toxicity (DLT) escalation. The aim of this study is to determine the safety and tolerability, as well as to evaluate the anti-tumor efficacy and pharmacokinetics of NMS-03305293 in combination with topotecan.",[26],"Ovarian Cancer","RECRUITING","2026-05-25",{"date":30,"type":31},"2026-05-28","ACTUAL",{"date":33,"type":31},"2026-05-13",{"date":35,"type":20},"2027-09-26",{"name":37,"class":38},"Nerviano Medical Sciences","INDUSTRY",5,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":47,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100587687","phase-1-study-of-nms-03305293-in-adult-patient-with-relapsed-small-cell-lung-cancer-100587687","NCT06931626","Study of NMS-03305293 in Adult Patient With Relapsed Small Cell Lung Cancer","Study of NMS-03305293, a Non-Trapping PARP1-Specific PARP Inhibitor in Relapsed Small Cell Lung Cancer","Inclusion Criteria -\n\n* Histologically confirmed extensive-stage Small Cell Lung Cancer (SCLC); must have failed prior front-line platinum-based therapy including immune therapy with relapse within 6 months followed by failed tarlatamab therapy, if available and appropriate, and no more than 3 total prior lines of systemic therapy (therapy terminated due to toxicity or drug shortage, in the absence of Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 progression, will be considered part of the same line). Sponsor may opt to allow history of treatment free interval from front-line longer than 6 months .\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n* Patient must have progressed radiographically on or after their most recent line of anticancer therapy and have measurable disease as defined by RECIST v1.1 (radiologically measured by the Investigator).\n* The interval from prior antitumor treatment should be at least 2 weeks or 5 half-lives, whichever longer.\n* All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 Grade ≤ 1 or to the baseline laboratory values as defined in the protocol.\n* Patients must use highly effective contraception or true abstinence.\n* Ability to swallow capsules intact (without chewing, crushing, or opening).\n\nExclusion Criteria -\n\n* Current enrollment in another interventional clinical trial.\n* Current treatment with other anticancer agents or devices.\n* Major surgery, other than surgery for recurrent SCLC, within 4 weeks prior to treatment start.\n* Patients with prior wide-field radiotherapy (RT) affecting at least 20 percent of the bone marrow.\n* Histologically transformed SCLC, i.e. tumors initially diagnosed as Non-Small Cell Lung Cancer (NSCLC) or mixed lung adenocarcinoma\n* Known paraneoplastic syndrome uncontrolled or that required therapeutic changes (either new\u002Facute or chronic) in the 14 days prior to study entry\n* Use of full-dose anticoagulants unless the International Normalized Ratio (INR) or a Partial Thromboplastin Time (PTT) is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose of anticoagulants for at least 2 weeks before enrollment.\n* Treatment with concomitant medications known to be sensitive substrates of CYP2D6 and CYP2C19 that cannot be replaced with another treatment.\n* Treatment with systemic immune modulators such as corticosteroids at prednisone equivalent dose of \\> 10 mg\u002Fday, cyclosporine and tacrolimus or radiotherapy within 28 days before treatment start.\n* Breast-feeding women or women planning to breast feed during the study or within 3 months after study treatment.\n* Known hypersensitivity to any component of NMS-03305293 or Temozolomide (TMZ) drug formulations.\n* Known active, life-threatening or clinically significant uncontrolled systemic infection (bacterial, fungal, viral including Human Immunodeficiency Virus \\[HIV\\] positivity or Hepatitis B Virus \\[HBV\\] or Hepatitis B Virus \\[HCV\\] infections) requiring systemic treatment; HIV or Acquired Immune Deficiency Syndrome (AIDS)-related illness are allowed as long as controlled more than 6 months to undetectable on anti-HIV medications.\n* Patients with QT interval using Fridericia standard (QTcF) interval \\>450 milliseconds or with risk factors for torsade de pointes (e.g., uncontrolled heart failure, uncontrolled hypokalemia, history of prolonged QTc interval or family history of long QT syndrome). For patients receiving treatment with concomitant medications known to prolong the QTc interval, replacement with another treatment prior to enrollment is mandatory. If concomitant use of anti-emetics is considered essential for the care of the patients, follow instruction in this protocol\n* Known active gastrointestinal disease (e.g., documented gastrointestinal ulcer, Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes or structural issues or ulcer that would impact on drug absorption.\n* Any of the following in the previous 6 months: myocardial infarction, unstable angina, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, active bleeding disorder and interstitial lung disease.\n* History of long QT disorder or familial sudden death syndromes or related syndromes in the opinion of the Investigator.\n* Currently active second malignancy, except for adequately treated basal or squamous cell skin cancer and\u002For cone biopsied or post curative intention in situ carcinoma of the cervix uteri and\u002For superficial bladder cancer.\n* Symptomatic, or untreated central nervous system (CNS) lesions except stable and well controlled with no neurological symptoms; patients receiving corticosteroids to control neurological symptoms should be on stable doses for at least 14 days before study entry.\n* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study or could compromise protocol objectives in the opinion of the Investigator and\u002For the Sponsor.\n\nNOTE: Other protocol defined inclusion and exclusion criteria may apply.","ALL",{"count":49,"type":20},10,[23],"This is an open-label study of NMS-03305293 with Temozolomide (TMZ) in patients with Small Cell Lung Cancer (SCLC). The aim of this study is to determine the safety and tolerability, as well as to evaluate the anti-tumor efficacy and pharmacokinetics of NMS-03305293 in combination with TMZ.",[53],"Small Cell Lung Cancer","2025-11-11",{"date":56,"type":31},"2025-11-12",{"date":58,"type":31},"2025-08-15",{"date":60,"type":20},"2027-02-28",{"name":37,"class":38},2,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":47,"minAge":17,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},"100558336","phase-1-study-of-nms-03597812-in-adult-patients-with-relapsedrefractory-acute-myeloid-leukemia-100558336","NCT06549790","Study of NMS-03597812 in Adult Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","A Phase Ia\u002FIb Study of NMS-03597812 in Adult Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia Including Patients With TP53 Mutations","Inclusion Criteria:\n\n* Confirmed diagnosis of refractory\u002Frelapsed (R\u002FR) AML according to 2022 ELN recommendation:\n\nPhase Ia\n\n* single agent dose escalation of NMS-03597812: R\u002FR AML patients who have exhausted standard therapy: a) prior fit patients to intensive chemotherapy (IC): failed at least one cycle of IC in front-line therapy or b) prior unfit to IC: failed at least 2 cycles of hypomethylating agents (HMA)\u002Fvenetoclax combination therapy, or at least 4 cycles of HMA monotherapy; c) patients must have failed all other approved therapies for which they are eligible, including FLT3 inhibitors, IDH1\u002F2 inhibitors, and CD33 directed therapy\n\nPhase Ib\n\n* Cohort A: single agent in R\u002FR AML TP53mt patients who have exhausted standard therapy: a) prior unfit to intensive chemotherapy (IC): failed at least 2 cycles of HMA\u002Fvenetoclax combination therapy, or at least 4 cycles of HMA monotherapy; b) patients must have failed all other approved therapies for which they are eligible, including FLT3 inhibitors, IDH1\u002F2 inhibitors, and CD33 directed therapy\n* Cohort B: single agent in R\u002FR AML TP53wt patients who have exhausted standard therapy: a) prior fit patients to intensive chemotherapy (IC): failed at least one cycle of IC in front-line therapy or b) prior unfit to IC: failed at least 2 cycles of HMA\u002Fvenetoclax combination therapy, or at least 4 cycles of HMA monotherapy; c) patients must have failed all other approved therapies for which they are eligible, including FLT3 inhibitors, IDH1\u002F2 inhibitors, and CD33 directed therapy\n* Adult (age ≥ 18 years) patients\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Unless agreed with sponsor, the interval from prior antitumor treatment should be at least 2 weeks or 5 half-lives, whichever is longer, other than hydroxyurea\n* All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to NCI CTCAE version 5.0 Grade≤ 1\n* Adequate organ function\n* Must use highly effective contraception or true abstinence. Female patients must be surgically sterile or, if patient is of childbearing potential, must agree to use effective contraception of therapy and in the following 210 days after discontinuation of study treatment. Since NMS-03597812 has potential induction of CYP3A4, women of childbearing potential must be advised that hormonal contraceptives might lose efficacy and must use alternate form of highly effective contraception. Male patients must be surgically sterile or must agree to use highly effective contraception or true abstinence during the period of therapy and in the following 120 days for male patients who must refrain from donating sperm during this period after discontinuation of study treatment.\n* Capability to swallow capsules intact (without chewing, crushing, or opening)\n* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study indications or procedures\n* Signed and dated Independent Ethics Committee (IEC) or Institutional Review Board (IRB)-approved informed consent form indicating that the patient is aware of the neoplastic nature of his\u002Fher disease and has been informed of the procedures to be followed, the investigational nature of the therapy, potential benefits, side effects, discomforts, risks, and alternative treatments.\n\nExclusion Criteria:\n\n* Current enrollment in another interventional clinical study unless only participating in survival follow up\n* White blood cells (WBC) count \\>20×10\\^3\u002Fmicroliter (μL). However, patients can be treated with hydroxyurea and\u002For leukapheresis prior to study treatment start to reduce the WBC to ≤ 20×10\\^3\u002FμL to enable eligibility for study drug dosing.\n* Diagnosis of acute promyelocytic leukemia or BCR-ABL-positive leukemia\n* Currently active second malignancy, except for adequately treated basal or squamous cell skin cancer and\u002For cone biopsied in situ carcinoma of the cervix uteri and\u002For superficial bladder cancer.\n* Patients with known leukemia involvement of central nervous system (CNS).\n* Hematopoietic stem cell transplantation (HSCT) within 3 months of treatment start and\u002For persistent non- hematologic toxicities of Grade ≥2 related to the transplant\n* Active acute or chronic graft versus host disease (GVHD) requiring immunosuppressive treatment\n* Patients with QTcF interval ≥ 470 milliseconds or with risk factors for torsade de pointes (e.g., uncontrolled heart failure, uncontrolled hypokalemia, history of prolonged QTc interval or family history of long QT syndrome). For patients receiving treatment with concomitant medications known to prolong the QTc interval, replacement with another treatment needs to be considered. If replacement or discontinuation is not clinically feasible, a careful risk\u002Fbenefit evaluation should be performed prior to enrollment.\n* Pregnancy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within the screening period prior to start of study drug.\n* Breast-feeding or planning to breast feed during the study or within 90 days after study treatment.\n* Known active gastrointestinal disease (eg, gastro-duodenal ulcer, gastrectomy, Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact on drug absorption.\n* Patient who are receiving concomitant medications with antacids (proton pump inhibitors are strictly prohibited; calcium carbonate antacids are only allowed 6 hours prior to a dose or 1 hour after). Note: exclusion criterion not applicable to optional backfill cohort for investigation of drug-drug interaction with antiacids.\n* Patient who are receiving concomitant medications that are strong inducers or inhibitors of CYP3A4 (with the exception of azole antifungals) and CYP2C9 that cannot be replaced with alternative therapy.\n* Patients who are receiving concomitant medications that are sensitive substrates of CYP3A4,CYP2D6, CYP1A2 and CYP2B6 with narrow therapeutic window that cannot be replaced with alternative therapy. Drugs with broad therapeutic indices may still be acceptable.\n* Patients who are receiving concomitant medications that are strong or moderate P-gp inhibitors that cannot be replaced with alternative therapy.\n* Major surgery within 4 weeks before study treatment start.\n* Radiotherapy within 4 weeks before study treatment start. However, if the radiation portal covered ≤5 % of the bone marrow reserve, the patient may be enrolled irrespective of the end date of radiotherapy.\n* History of necrotic pancreatitis or acute severe pancreatitis, requiring medical intervention and\u002For hospitalization, in the previous 6 months before study treatment start.\n\nNOTE: Other protocol defined inclusion\u002Fexclusion criteria may apply.",{"count":71,"type":20},124,[23],"The aim of PERKA-812-003 study is to investigate the safety, pharmacokinetics and preliminary anti-tumor activity of treatment with NMS-03597812 as single agent in Relapsed\u002FRefractory Acute Myeloid Leukemia (R\u002FR AML) patients who have exhausted standard treatment, including a subset of patients with TP53 mutations. It is anticipated that combination with venetoclax will be further evaluated following a future protocol amendment, once the Recommended Range Dose (RDR) as single agent has been defined.",[75],"Relapsed\u002FRefractory Acute Myeloid Leukemia",[77,75,78],"Leukemia","TP53 mutations","2025-10-30",{"date":81,"type":31},"2025-10-31",{"date":83,"type":31},"2024-10-16",{"date":85,"type":20},"2030-05-15",{"name":37,"class":38},7,""]